A Third Category? Medicines Go Behind the Counter

Author: Wendy K. Bodine, Assistant Editor

Last year's controversies surrounding
which patients should be able
to access the emergency contraception
pill Plan B (levonorgestrel) and
the decongestant pseudoephedrine (PSE)
have sent these medications into the
pharmaceutical limbo known as behind
the counter (BTC). In a middle ground
between OTC and prescription-only medicines,
these products are designated to
be accessed by patients only after discussion
with the pharmacist and presenting
proof of identification (ID). The reasoning
behind putting certain drugs behind the
pharmacy counter was to limit their use
by those who might misuse them, while
still maintaining reasonable access for
legitimate patients without making them
get a prescription.

Pseudoephedrine (PSE)

A popular and effective decongestant,
PSE has been recommended by physicians
and pharmacists for many years.
When the Drug Enforcement Administration
found that it was being used to
make illegal methamphetamine, however,
PSE was moved BTC to discourage
bulk sales and shoplifting of the drug.
Now, patients seeking congestion relief
from PSE must sign log books in addition
to presenting IDs in order to access the
medication. Although some pharmacists
hoped that this would encourage more
dialogue between patients and pharmacists
about medications, they are finding
that the inconvenience is putting some
patients off PSE altogether.

A number of pharmacists suspect that
some patients, perhaps unaware of the
new regulation, become confused by
replacement drugs that substitute
phenylephrine (PE) for PSE because they
are packaged similarly to the original
products. They claim this is one possible
reason behind the drop in sales of such
PSE regulars as Sudafed and its generic
equivalents. Alan Rosenthal, RPh, of the
Suburban Pharmacy in West Hartford,
Conn, fears that patients are accidentally
settling for cold products that are not as
effective as those they can access from
BTC. He admits being asked by patients
about the efficacy of PE. "I tell them that
PSE is a better product,"
he said.

Schering-Plough revealed
in its third-quarter
report that sales of OTC
Claritin had increased 4%
to $95 million, due to reformulation
with PE instead
of PSE. Sales of Claritin-D,
which still contains PSE,
had fallen, however, although
the company did
not disclose exact figures.

Plan B

In August 2006, the FDA
agreed to approve Plan B
as an OTC medicine for
women aged 18 and
older. To enforce the regulation, however,
pharmacists will have to keep the product
BTC; patients seeking the drug must
first provide proof of age. Some argue
that this is not true OTC status because it
does not allow access to medications
outside of pharmacist intervention.

Barr Pharmaceuticals, which makes
Plan B, began shipping the OTC version to
pharmacies in mid-November of last
year. Most major pharmacies, such as
Wal-Mart, are using the "conscientious-objection"
policy, which allows a pharmacist
who objects to selling Plan B on
moral or religious grounds to step away
from the transaction and allow a coworker
to complete it. Most other major
chains will also carry the drug, but, surprisingly,
some independents are debating
whether to supply the drug at all due
to lack of previous demand. Ike Vlahos,
owner of Jonestown Pharmacy in
Winston-Salem, NC, said in the past 2
years he has had only 4 prescriptions
come in for Plan B, and he probably will
not carry the OTC version. "I don't know
how the public will feel about stepping up
to the counter and asking for it," he said.

An Official Third Class?

Several countries, including the United
Kingdom (UK), Canada, and Australia,
already have an official class for drugs
available from BTC, referred to as "pharmacy
(P)," "pharmacist only," or
"Schedule 3." In the UK, half of the medicines
available without a prescription fall
into this category.

To establish a new class of drugs,
Congress would have to issue an official
act. It considered doing so in the early
1990s, when it studied the US General
Accounting Office's report on how third-class
drugs fared in other countries. The
report effectively shot down the idea of
an American BTC class, stating that the
experience of other countries "does not
support a fundamental change in the US
system."

Gary Stein, a government affairs specialist
for the American Society of Health-
System Pharmacists, stated that pharmaceutical
companies might demand
that the class be established. "If [they]
see drugs they'd like to go to OTC status
get rejected, that might encourage the
FDA to move to this," he said. Some
brand name manufacturers hope that a
BTC class could help them extend the
lives of drugs about to go off patent. As
of now, OTC status gives branded drugs
about 3 more years of exclusivity, but
drug makers usually meet with opposition
when dealing with medicines for
chronic conditions that have no visible
symptoms, such as high cholesterol.

In January 2005, Merck & Co Inc lost a
bid to the FDA to have its prescription
cholesterol-lowering statin drug Mevacor
(lovastatin) transferred to OTC status.
Members of the FDA advisory panel,
however, stated that they could support
offering it to patients from behind the
pharmacists' counter without a prescription.
It seems that many on the committee
believe patients could accurately
determine their own need for cholesterol-
lowering medications without consulting
their physicians. Noting that in the
UK Zocor (simvastatin) is already offered
under BTC status, FDA panel member
Leslie Clapp stated that "the BTC scenario
would be a perfect solution" for Mevacor.

Some feel that installing a third class of
medicine would provide a much needed
boost to pharmacistsnot just in their
budgets, but in their morale as well. Janet
Engle, associate dean of the University of
Illinois at Chicago College of Pharmacy,
stated that, as pharmacists, "none of us
went into the profession to stand behind
a counter and count by fives." She
agreed that pharmacists want to
become more involved in their patients'
health care, and BTC medicines would
encourage that interaction.

Michael Capka, pharmacist for Happy
Harry's in Wilmington, Del, agreed that "it
would help everybodythe public, pharmacistsif there was this third class of
drugs." He said that one of the most satisfying
things about the BTC process is
being able to advise patients about their
conditions when they come to get their
medicines from BTC. "You can actually
see a patient's face start to light up."

Others feel a third class of drugs is
unnecessary. Virginia Cox of the
Consumer Healthcare Products Association,
a trade group for nonprescription
drugs and dietary supplements,
however, expressed hesitation at the
instigation of a third class of drugsa
move that might harm many members of
her group by limiting access to their
products. Arthur Levin, director of the
Center for Medical Consumers, said he
does not see the point of a third drug
class. He says that, although pharmacists
might reach out for this as an opportunity
to counsel patients, "that doesn't happen
very much in the hurly-burly of the
retail establishment."

In the UK, enforcement of the BTC status
is occasionally a bit lax. "I've gone
into the UK and bought something BTC,"
said Alastair Wood, a pharmacologist at
Vanderbilt University, who chaired the
FDA committee that voted on Mevacor.
He stated that when he asked for BTC
products, most times he was just handed
the product without being asked for ID.
Sheila Kelly, executive director of the
Proprietary Association of Great Britain,
explained that "in practice...most [BTC]
sales are made to people who have
bought the products many times before."
Experts in the United States, however,
fear that this familiarity would become
an opportunity for such medicines to end
up in the wrong hands.

Conclusion

Although several medications have
had to go BTC in the United States in
recent years, the idea of installing an official
third class has yet to catch on with
the majority of Americans. As more
branded drugs go off patent and face
generic competition in the "prescription-only"
market, however, there may be
more insistence from pharmaceutical
companies to reopen the idea of a federally
mandated third class of medicines.